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Clinical trial No longer in our active list Phase 2 Interventional Ages 18 to 70

Evaluating Palmitoylethanolamide for Bipolar Depression

Official title: A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

Run by The University of Texas Health Science Center, Houston · NCT06229977 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if a supplement called Palmitoylethanolamide can help people with Bipolar Depression feel better compared to a placebo or standard treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment50 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
Trial IDNCT06229977 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with Bipolar Disorder who are currently on at least one FDA-approved mood stabilizer and have moderate to severe depressive symptoms.

Probably not a fit

Patients with active substance use disorders, acute suicidal risk, or those experiencing manic episodes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the antidepressant effects of Palmitoylethanolamide (PEA) in patients diagnosed with Bipolar Depression. It will also explore the relationship between the antidepressant response and levels of endogenous cannabinoids and cytokines. Participants will receive either PEA, a placebo, or treatment as usual, while their mood and biological markers will be monitored throughout the trial. The study is designed to provide insights into the efficacy of PEA as a potential treatment option for this condition.

Why it matters

Potential benefit: If successful, this study could offer a new therapeutic option for patients suffering from Bipolar Depression.

How similar studies have gone: While the specific use of PEA in Bipolar Depression is novel, other studies have explored cannabinoid-based treatments with varying degrees of success.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
* currently in use of at least one FDA approved mood stabilizer with or without antidepressant
* medically and neurologically healthy on the basis of medical history, physical examination

Exclusion Criteria:

* Cannabis misuse according to clinical judgement
* unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
* active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
* acute high suicidal risk
* in a manic episode
* current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
* pregnant or nursing women
* unstable medical conditions
* clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available

Where it's running

  • The University of Texas Health Science Center at Houston
    Houston, Texas, United States     Recruiting

Study contacts

  • Principal investigator: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc — The University of Texas Health Science Center, Houston
  • Study coordinator: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
  • Email: Rodrigo.MachadoVieira@uth.tmc.edu
  • Phone: (713) 486-2581

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.